Technical report demonstrates the effectiveness of Macroduster™ in inactivating macrolide antibiotics for microbiological quality control

Analytical enzyme specialist CPC Biotech Srl has published a technical report demonstrating the effectiveness of its enzyme-based product Macroduster™ in inactivating the antimicrobial activity of macrolide antibiotics during microbiological quality control.

International Pharmacopoeias require pharmaceutical products to meet microbiological purity criteria, including the removal or neutralisation of antimicrobial activity where necessary to ensure valid microbiological quality control testing.

CPC Biotech has developed Macroduster™ to inactivate a broad range of macrolide antibiotics commonly used to treat both Gram-positive and Gram-negative infections.

The White Paper provides detailed results of three different tests:

• Kirby-Bauer testing demonstrated Macroduster’s ability to inactivate erythromycin, azithromycin and clarithromycin, with additional testing confirming activity against other macrolides including roxithromycin and gamithromycin.
• An external independent accredited analytical lab developed microbial enumeration protocol for the microbiological examination of non-sterile azithromycin and clarithromycin tablets, using Macroduster™ as the inactivating agent to validate microbiological quality control testing.
• Testing for specified microorganisms (Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa) confirmed that Macroduster™ enabled recovery of the target organisms following macrolide inactivation.

Across all three testing programmes, Macroduster™ consistently demonstrated effective macrolide inactivation while supporting validated microbiological quality control methods. The findings confirm its value as an enzyme-based solution for microbiological sterility testing, microbial enumeration and other pharmaceutical microbiology applications requiring reliable neutralisation of macrolide antibiotic activity.